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Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

NCT01167725 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2024-12-27

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C.

PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer

Conditions

Interventions

BIOLOGICAL

bevacizumab

Given IV

BIOLOGICAL

cetuximab

Given IV

DRUG

FOLFIRI regimen

Given IV

DRUG

FOLFOX regimen

Given IV

DRUG

capecitabine

Given IV

DRUG

fluorouracil

Given IV

DRUG

irinotecan hydrochloride

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

mitomycin C

Given intraperitoneally

DRUG

oxaliplatin

Given IV

PROCEDURE

therapeutic conventional surgery

Patients undergo cytoreductive surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Alexander Stojadinovic, MD · Walter Reed Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167725 on ClinicalTrials.gov